Drug application

EFAVIRENZ (EFAVIRENZ)

Drugs@FDA ANDA 091471 · MYLAN

Key facts

Drug name EFAVIRENZ
Active ingredients EFAVIRENZ
Application type ANDA
Application number 091471
Company MYLAN
Dosage forms TABLET, ORAL
Strength 600MG
Marketing status Discontinued
Reference listed drug No
Latest submission status date Feb 17, 2016

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • No FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

Browse all Drugs@FDA applications